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Last Updated: December 22, 2024

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE - Generic Drug Details


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What are the generic sources for dextrose; potassium chloride; sodium chloride and what is the scope of freedom to operate?

Dextrose; potassium chloride; sodium chloride is the generic ingredient in one hundred and thirteen branded drugs marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, and Icu Medical Inc, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
US Patents:0
Tradenames:113
Applicants:4
NDAs:13
Finished Product Suppliers / Packagers: 4
DailyMed Link:DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE at DailyMed
Pharmacology for DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

US Patents and Regulatory Information for DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019308-006 Apr 5, 1985 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-012 Jan 18, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018008-004 Approved Prior to Jan 1, 1982 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Icu Medical Inc POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018365-008 Mar 28, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Icu Medical Inc POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018876-006 Mar 28, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-047 Feb 17, 1988 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Potassium Chloride in Dextrose and Sodium Chloride Injection

Introduction

Potassium Chloride in Dextrose and Sodium Chloride Injection is a multifaceted intravenous solution used as a source of water, electrolytes, and calories. This article delves into the market dynamics and financial trajectory of this drug, highlighting its indications, usage, market trends, and financial aspects.

Indications and Usage

This injection is indicated for patients requiring hydration, electrolyte replacement, and caloric intake, particularly when oral nutrition is not feasible. It is commonly used in clinical settings to treat conditions such as hypokalemia, dehydration, and in cases where enteral nutritional supply is insufficient or impossible[2][4].

Market Demand

The demand for Potassium Chloride in Dextrose and Sodium Chloride Injection is driven by several factors:

Clinical Necessity

The need for intravenous hydration and electrolyte replacement is constant in healthcare settings, ensuring a steady demand for this product.

Diverse Clinical Applications

Its use in various clinical conditions, including pre- and post-operative care, intensive care units, and emergency medicine, broadens its market reach[2].

Pediatric and Neonatal Care

Although the safety and effectiveness in pediatric patients are not fully established, it is still used in these populations under careful monitoring, contributing to its market demand[1].

Market Trends

Product Variations

The market offers various concentrations of Potassium Chloride, Dextrose, and Sodium Chloride, catering to different clinical needs. For example, solutions with 0.2%, 0.33%, 0.45%, and 0.9% Sodium Chloride are available, each with different potassium chloride concentrations[1][4].

Technological Advancements

Updates in test methods related to expiration dating, as seen in recent price increase justifications, indicate ongoing efforts to improve product quality and shelf life[3].

Regulatory Compliance

Manufacturers must adhere to strict regulatory guidelines, which can influence production costs and pricing strategies. Contraindications and precautions, such as avoiding use in patients with hyperkalemia or severe renal failure, also shape market dynamics[2][4].

Financial Trajectory

Pricing

The pricing of Potassium Chloride in Dextrose and Sodium Chloride Injection can vary based on the concentration of its components and the volume of the solution. Recent data shows price increases due to updated test methods and other factors, with prices ranging from $9.04 to $9.79 per unit for different concentrations[3].

Revenue Streams

The revenue generated from this product is substantial due to its widespread use in healthcare facilities. The market is driven by both the volume of sales and the pricing strategy of manufacturers.

Cost Factors

Manufacturing costs, including the cost of raw materials (dextrose, potassium chloride, and sodium chloride), production processes, and regulatory compliance, influence the financial trajectory. Additionally, the cost of maintaining a long shelf life (typically 18 months) and ensuring product quality also plays a significant role[5].

Competitive Landscape

Market Players

Several pharmaceutical companies, including B. Braun Medical Inc. and ICU Medical, are key players in this market. Each company competes based on product quality, pricing, and customer service[3][5].

Product Differentiation

Differentiation is achieved through varying concentrations of the components, packaging options (e.g., flexible containers), and the shelf life of the products. Companies also focus on improving the safety and efficacy of their products to gain market share[1][5].

Challenges and Opportunities

Clinical Risks

The administration of this injection can lead to several clinical risks, including fluid and solute overloading, hyperosmolality, and electrolyte imbalances. These risks necessitate careful monitoring and management, which can impact market dynamics[1][2].

Regulatory Challenges

Compliance with regulatory requirements is a significant challenge. Manufacturers must ensure that their products meet stringent safety and efficacy standards, which can be costly and time-consuming[2][4].

Market Opportunities

The growing need for intravenous solutions in emerging markets and the increasing complexity of healthcare needs present opportunities for growth. Innovations in product formulation and delivery systems can also expand market share[2].

Key Takeaways

  • Steady Demand: The constant need for hydration and electrolyte replacement in healthcare settings ensures a steady market demand.
  • Diverse Applications: The product's use in various clinical conditions broadens its market reach.
  • Regulatory Compliance: Adherence to regulatory guidelines is crucial and influences production costs and pricing.
  • Financial Factors: Pricing, revenue streams, and cost factors such as raw materials and production processes shape the financial trajectory.
  • Competitive Landscape: Market competition is driven by product quality, pricing, and customer service.

Frequently Asked Questions (FAQs)

Q: What are the common indications for Potassium Chloride in Dextrose and Sodium Chloride Injection? A: This injection is indicated as a source of water, electrolytes, and calories, particularly in cases where oral nutrition is not feasible.

Q: What are the potential risks associated with the administration of this injection? A: Risks include fluid and solute overloading, hyperosmolality, electrolyte imbalances, and in severe cases, pulmonary edema.

Q: Can this injection be used in pediatric patients? A: While safety and effectiveness in pediatric patients are not fully established, it is used under careful monitoring, especially in neonates and low birth weight infants.

Q: How do regulatory compliance and updates in test methods affect the market? A: Regulatory compliance and updates in test methods can influence production costs and pricing strategies, ensuring product quality and shelf life.

Q: What are the key factors influencing the pricing of this injection? A: Pricing is influenced by the concentration of components, volume of the solution, manufacturing costs, and regulatory compliance.

More… ↓

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